European Commission Approves XEPLION® for Treatment of Schizophrenia

Beerse, Belgium (March 9, 2011) — Janssen-Cilag International NV today announced that XEPLION® (paliperidone palmitate), a once monthly, long-acting injectable, antipsychotic, has received approval from the European Commission for the treatment of schizophrenia.

 Schizophrenia is relatively common and the prevalence is similar around the world. The lifetime risk for schizophrenia is estimated to be one person in 100, and appears to be the same for men and women up to age 60 years.[1] Schizophrenia is a devastating mental illness for both the patients and their families and friends, as it seriously impairs a person’s ability to think clearly, relate to others and to function properly in society. While there is no cure, many people with the illness respond well to antipsychotic medicines, the mainstay of treatment for schizophrenia.

 However, further relapses can have a terrible effect on the lives of patients with schizophrenia and their families. Frequent relapses and hospitalisation can increase the person’s isolation and make it even more difficult for them to find and keep a job.[2],[3],[4],[5],[6] Prevention of future relapses is a crucial goal of therapy and patients who stay on continual treatment are more likely to achieve optimal outcomes.[7],[8]

 Patients with schizophrenia who are non-adherent to medication are up to five times more likely to relapse than those patients who are adherent and continue on medication, significantly increasing the likelihood of hospitalisation,[9] which in turn increases the overall cost of care.

 “Relapse can have a devastating effect on patients with schizophrenia and more needs to be done to actively improve adherence to medication if we are to break the cycle of decline,” said Professor Fernando Cañas, Head of Department of Psychiatry, Hospital Dr Rodríguez Lafora, Madrid, Spain.* “Long-acting injectable antipsychotics such as XEPLION® can help patients to maintain continual treatment, thereby reducing the likelihood of relapse. This is imperative not only to reduce the suffering and cost burden associated with relapse in schizophrenia, but to improve the future outlook and overall quality of life for these patients.”

The Clinical Data

 The efficacy of XEPLION® was established in four double-blind placebo controlled studies in patients with an acute exacerbation of schizophrenia and a longer-term double blind relapse prevention/maintenance study.[10],[11] ,[12],[13],[14] XEPLION® was superior to placebo in improving symptoms of schizophrenia as measured by the change in the positive and negative syndrome scale (PANSS) total scores from baseline to endpoint in the acute treatment trials and significantly delayed time to relapse vs. placebo in the longer-term maintenance study.[15]

 The most recent acute symptom control study was a multi-centre, randomised, placebo-controlled, double-blind, parallel-group study (n=636). [10] All patients received a dose of 150 mg eq. on Day 1 in the deltoid muscle. From Day 8 and monthly thereafter, patients were assigned to one of three fixed doses of XEPLION® (25, 100 and 150 mg eq) administered into either the deltoid or gluteal muscle for a period of 13 weeks. All three doses of XEPLION® were superior to placebo in improving the PANSS total score at endpoint (the primary measure of efficacy). The results support efficacy across the entire duration of treatment, with onset of efficacy and significant improvement in PANSS compared to placebo observed from day 8 in some patients. The results of the other studies also yielded significant results in favour of XEPLION®.[13]

 The efficacy of XEPLION® in maintaining symptomatic control and delaying relapse in schizophrenia was established in a longer-term, randomised, double-blind, placebo-controlled, flexible-dose study involving 849 patients with schizophrenia.[14] A total of 410 stabilised patients were randomised to either XEPLION® or to placebo until they experienced a relapse of schizophrenia symptoms in the variable length double-blind phase of the study. The trial was stopped early for efficacy reasons as a significantly longer time to relapse (p < 0.0001) was seen in patients treated with XEPLION® compared to placebo. During the double-blind phase of the study, fewer patients treated with XEPLION® experienced a relapse (10% [n=15/156]) compared with those in the placebo group (34% [n=53/156]).[14] The final analyses confirmed the results of the interim analysis.

 “XEPLION® provides healthcare professionals with the opportunity to rethink their overall approach to how they treat schizophrenia by using long-acting therapies,” says Dr Christophe Tessier**, Medical Affairs Director, Psychiatry, Janssen EMEA. “The approval of XEPLION® demonstrates Janssen’s ongoing commitment to providing novel therapies for schizophrenia. As a once monthly injection, XEPLION® can help healthcare professionals address the issue of non-adherence to medication thus ensuring symptom control and allowing patients to focus on shaping their lives.”

About XEPLION® (paliperidone palmitate)

XEPLION® is a once-monthly, long-acting, injectable, atypical antipsychotic. XEPLION® will be available in Europe in milligrams (mg) of paliperidone palmitate in dose strengths of 25***, 50, 75, 100 and 150 mg. After the first two initiation injections, XEPLION® can be administered in either the deltoid (arm) or gluteal (buttock) muscle.

 The approved indication is:

 XEPLION® is indicated for maintenance treatment of schizophrenia in adult patients stabilised with paliperidone or risperidone. In selected adult patients with schizophrenia and previous responsiveness to oral paliperidone or risperidone, XEPLION® may be used without prior stabilisation with oral treatment if psychotic symptoms are mild to moderate and a long-acting injectable treatment is needed.

Tolerability

 In the clinical development programme XEPLION® was generally well tolerated with no new safety signals identified in comparison to oral paliperidone ER with the exception of local injection site reactions.[10-14] The most frequently reported adverse effects during the clinical trials were insomnia (difficulty sleeping), headache, weight increase, injection site reactions, agitation, somnolence, akathisia (restlessness), nausea, constipation, dizziness, tremor, vomiting, upper respiratory tract infection (infection of the nose, throat, or chest), diarrhoea, and tachycardia (rapid heart rate).[15]

 XEPLION® was developed utilising Elan Drug Technologies’ proprietary NanoCrystal® Technology. Using this technology increases the rate of dissolution and enables the formulation of an aqueous suspension for once-monthly intramuscular administration.

About Schizophrenia

 Schizophrenia is a chronic, severe and disabling brain disorder that seriously impairs a person’s ability to think clearly, relate to others and to function productively in society. The consequences of the disorder include difficulties in thought processes leading to hallucinations, delusions, disordered thinking and unusual speech or behaviour.

About Janssen

 Janssen-Cilag International NV is one of the Janssen Pharmaceutical Companies of Johnson & Johnson, which are dedicated to addressing and solving the most important unmet medical needs of our time, including oncology (e.g. multiple myeloma and prostate cancer), immunology (e.g. psoriasis), neuroscience (e.g. schizophrenia, dementia and pain), infectious disease (e.g. HIV/AIDS, Hepatitis C and tuberculosis), and cardiovascular and metabolic diseases (e.g. diabetes). Driven by our commitment to patients, we develop sustainable, integrated healthcare solutions by working side-by-side with healthcare stakeholders, based on partnerships of trust and transparency. More information can be found at http://www.janssen-emea.com

 (This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Janssen-Cilag International NV’s and/or Johnson & Johnson’s expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 2, 2011. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither Janssen-Cilag International NV nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.)

 Notes

 * Professor Fernando Cañas has at times been a paid consultant of Janssen.

 ** Dr Christophe Tessier is a full time employee of Janssen, EMEA.

 *** 25mg will not be available in all countries.

 References

 ———————————

 [1] Lehman A et al. Practice guideline for the treatment of patients with schizophrenia, second edition. Am J Psychiatry. 2004;161(2 Suppl):1-56

 [2] Thornicroft G, Brohan E, Rose D, et al for the INDIGO Study Group. Lancet.2009;373(9661):408-15.

 [3] Marwaha S, Johnson S, Bebbington P, et al. Br J Psychiatry. 2007;191:30-7.

 [4] Marwaha S, Johnson S. Soc Psychiatry Psychiatr Epidemiol. 2004;39(5):337-49.

 [5] Nithsdale V, Davies J, Croucher P. J Occup Rehabil. 2008;18(2 ):175-82.

 [6] Rosenheck R, Leslie D, Keefe R, et al; CATIE Study Investigators Group. Am J Psychiatry. 2006;163(3):411-417.

 [7] Masand PS, Roca M, Turner MS et al. Partial adherence to antipsychotic medication impacts course of illness in patients with schizophrenia: a review. Prim Care Companion J Clin Psychiatry. 2009;11(4):147-54.

 [8] Peuskens J, Olivares JM, Pecenak J et al. Treatment retention with risperidone long-acting injection: 24-month results from the Electronic Schizophrenia Treatment Adherence Registry (e-STAR) in six countries. Curr Med Res Opin 2010;26:501-509

 [9] Kane JM. Treatment adherence and long-term outcomes. CNS Spectrums. 2007: 12 (10 Suppl 17), 21-26.

 [10] Pandina et al. A Randomised, Placebo Controlled Study to Assess the Efficacy and Safety of 3 Doses of paliperidone Palmitate in Adults With Acutely Exacerbated Schizophrenia. J Clin Psychopharmacol. 2010; 30: 235-244.

 [11] Nasrallah HA et al. A controlled evidence based trial of paliperidone palmitate, a long-acting injectable antipsychotic, in schizophrenia. Neuropsychopharmacology. 2010; 35(10): 207-282.

 [12] Gopal S et al. Efficacy and safety of paliperidone palmitate in adult patients with acutely symptomatic schizophrenia: a randomized, double-blind, placebo-controlled, dose-response study. Int Clin Psychopharmacology. 2010; 25(5): 24756

 [13] Kramer et al. Paliperidone palmitate, a potential long-acting treatment for patients with schizophrenia. Results of a randomized, double-blind, placebo-controlled efficacy and safety study. Int J Neuropsychopharmacology. 2009; 27: p113.

 [14] Hough D et al. Paliperidone palmitate maintenance treatment in delaying the time to relapse in patients with schizophrenia: A randomized, double-blind placebo-controlled study. Schizophrenia Research. 2010; 116 (23): 107-117.

 [15] Xeplion® SmPC 2011

Source: http://www.jnj.com/connect/news/all/european-commission-approves-xeplion-for-treatment-of-schizophrenia

Related posts

• The Side Effects Of Common Psychiatric Drugs: Antipsychotics (0)
• Valium (diazepam) (0)
• The Side Effects Of Common Psychiatric Drugs: Newer Antidepressants (0)
• The Side Effects Of Common Psychiatric Drugs: Lithium (0)
• The Side Effects Of Common Psychiatric Drugs: Anti-Anxiety Drugs (0)
• Sertraline (0)
• The Side Effects Of Common Psychiatric Drugs: Older Antidepressants (0)
• Tegretol (0)
• Discontinuing Antidepressants (0)
• Alprazolam (0)

Generic name: aripiprazole

Read this Medication Guide before you start taking ABILIFY and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment.

What is the most important information I should know about ABILIFY (aripiprazole)?

(For other side effects, also see “What are the possible side effects of ABILIFY?”).

Serious side effects may happen when you take ABILIFY, including:

• Increased risk of death in elderly patients with dementia-related psychosis: Medicines like ABILIFY can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). ABILIFY is not approved for the treatment of patients with dementia-related psychosis.

• Risk of suicidal thoughts or actions: Antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions:

1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.

2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.

3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?

• Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.

• Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.

• Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:

• thoughts about suicide or dying

• attempts to commit suicide

• new or worse depression

• new or worse anxiety

• feeling very agitated or restless

• panic attacks

• trouble sleeping (insomnia)

• new or worse irritability

• acting aggressive, being angry, or violent

• acting on dangerous impulses

• an extreme increase in activity and talking (mania)

• other unusual changes in behavior or mood

What else do I need to know about antidepressant medicines?

• Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.

• Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.

• Antidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.

• Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.

• Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child’s healthcare provider for more information.

What is ABILIFY?

ABILIFY is a prescription medicine used to treat:

• schizophrenia in people age 13 years and older.

• bipolar I disorder in people age 10 years and older, including:

• manic or mixed episodes that happen with bipolar I disorder.

• manic or mixed episodes that happen with bipolar I disorder, when used with the medicine lithium or valproate.

• long-term treatment of bipolar I disorder.

• major depressive disorder in adults, as an add-on treatment to an antidepressant medicine when you do not get better with an antidepressant alone.

• irritability associated with autistic disorder in children and adolescents ages 6 to 17 years old.

• agitation associated with schizophrenia or bipolar disorder.

The symptoms of schizophrenia include:

• losing touch with reality (psychosis)

• seeing things or hearing voices that are not there (hallucinations)

• believing things that are not true (delusions)

• being suspicious (paranoia)

• disorganized speech and thinking

• bizarre behavior

The symptoms of bipolar I disorder include:

• extreme mood swings that include feeling depressed and high or irritable mood

• talking too fast and too much

• impulsive behavior

• having more energy and restlessness than usual

• needing less sleep than usual

The symptoms of major depressive disorder (MDD) include:

• feeling of sadness and emptiness

• loss of interest in activities that you once enjoyed and loss of energy

• problems focusing and making decisions

• feeling of worthlessness or guilt

• changes in sleep or eating patterns

• thoughts of death or suicide

The symptoms of irritability associated with autistic disorder include:

• aggressive behavior towards others

• intentionally trying to harm oneself

• temper tantrums

• quickly changing moods

The symptoms of agitation associated with schizophrenia or bipolar disorder include:

• hostility or aggressive behavior

• agitation and inner tension

• self-exhausting behavior

What should I tell my healthcare provider before taking ABILIFY?

Before taking ABILIFY, tell your healthcare provider if you have or had:

• diabetes or high blood sugar in you or your family; your healthcare provider should check your blood sugar before you start ABILIFY and also during therapy.

• seizures (convulsions).

• low or high blood pressure.

• heart problems or stroke.

• pregnancy or plans to become pregnant. It is not known if ABILIFY will harm your unborn baby.

• breast-feeding or plans to breast-feed. It is not known if ABILIFY will pass into your breast milk. You and your healthcare provider should decide if you will take ABILIFY or breast-feed. You should not do both.

• low white blood cell count.

• phenylketonuria. ABILIFY DISCMELT Orally Disintegrating Tablets contain phenylalanine.

• any other medical conditions.

Tell your healthcare provider about all the medicines that you take or recently have taken, including prescription medicines, non-prescription medicines, herbal supplements, and vitamins.

ABILIFY and other medicines may affect each other causing possible serious side effects. ABILIFY may affect the way other medicines work, and other medicines may affect how ABILIFY works.

Your healthcare provider can tell you if it is safe to take ABILIFY with your other medicines. Do not start or stop any medicines while taking ABILIFY without talking to your healthcare provider first. Know the medicines you take. Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine.

How should I take ABILIFY?

• Take ABILIFY exactly as your healthcare provider tells you to take it.

Do not change the dose or stop taking ABILIFY yourself.

• ABILIFY can be taken with or without food.

• ABILIFY tablets should be swallowed whole.

• If you miss a dose of ABILIFY, take the missed dose as soon as you remember. If it is almost time for the next dose, just skip the missed dose and take your next dose at the regular time. Do not take two doses of ABILIFY at the same time.

• If you have been prescribed ABILIFY DISCMELT, take it as follows:

• Do not open the blister until ready to take the DISCMELT tablet.

• To remove one DISCMELT tablet, open the package and peel back the foil on the blister to expose the tablet.

• Do not push the tablet through the foil because this could damage the tablet.

• Immediately upon opening the blister, using dry hands, remove the tablet and place the entire ABILIFY DISCMELT Orally Disintegrating Tablet on the tongue.

• Tablet disintegration occurs rapidly in saliva. It is recommended that ABILIFY DISCMELT be taken without liquid. However, if needed, it can be taken with liquid.

• Do not attempt to split the DISCMELT tablet.

• If you take too much ABILIFY, call your healthcare provider or poison control center at 1-800-222-1222 right away, or go to the nearest hospital emergency room.

What should I avoid while taking ABILIFY?

• Do not drive, operate heavy machinery, or do other dangerous activities until you know how ABILIFY affects you. ABILIFY may make you drowsy.

• Do not drink alcohol while taking ABILIFY.

• Avoid getting over-heated or dehydrated.

• Do not over-exercise.

• In hot weather, stay inside in a cool place if possible.

• Stay out of the sun. Do not wear too much or heavy clothing.

• Drink plenty of water.

What are the possible side effects of ABILIFY?

Serious side effects have been reported with ABILIFY including: Also see “What is the most important information I should know about ABILIFY?” at the beginning of this Medication Guide.

• Neuroleptic malignant syndrome (NMS): Tell your healthcare provider right away if you have some or all of the following symptoms: high fever, stiff muscles, confusion, sweating, changes in pulse, heart rate, and blood pressure. These may be symptoms of a rare and serious condition that can lead to death. Call your healthcare provider right away if you have any of these symptoms.

• High blood sugar (hyperglycemia): Increases in blood sugar can happen in some people who take ABILIFY. Extremely high blood sugar can lead to coma or death. If you have diabetes or risk factors for diabetes (such as being overweight or a family history of diabetes), your healthcare provider should check your blood sugar before you start ABILIFY and during therapy.

Call your healthcare provider if you have any of these symptoms of high blood sugar while taking ABILIFY:

• feel very thirsty

• need to urinate more than usual

• feel very hungry

• feel weak or tired

• feel sick to your stomach

• feel confused, or your breath smells fruity.

• Difficulty swallowing: may lead to aspiration and choking.

• Tardive dyskinesia: Call your healthcare provider about any movements you cannot control in your face, tongue, or other body parts. These may be signs of a serious condition. Tardive dyskinesia may not go away, even if you stop taking ABILIFY. Tardive dyskinesia may also start after you stop taking ABILIFY.

• Orthostatic hypotension (decreased blood pressure): lightheadedness or fainting when rising too quickly from a sitting or lying position.

• Low white blood cell count

• Seizures (convulsions)

Common side effects with ABILIFY in adults include:

• nausea • inner sense of restlessness/need to move

• vomiting (akathisia)

• constipation • anxiety

• headache • insomnia

• dizziness • restlessness

Common side effects with ABILIFY in children include:

• feeling sleepy • insomnia

• headache • nausea

• vomiting • stuffy nose

• fatigue • weight gain

• increased appetite • uncontrolled movement such as restlessness, tremor, muscle stiffness

These are not all the possible side effects of ABILIFY. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store ABILIFY?

• Store ABILIFY at room temperature, between 59°F to 86°F (15°C to 30°C).

• Opened bottles of ABILIFY Oral Solution can be used for up to

6 months after opening, but not beyond the expiration date on the bottle.

Keep ABILIFY and all medicines out of the reach of children.

General information about ABILIFY

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ABILIFY for a condition for which it was not prescribed. Do not give ABILIFY to other people, even if they have the same condition. It may harm them.

This Medication Guide summarizes the most important information about ABILIFY. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about ABILIFY that was written for healthcare professionals. For more information about ABILIFY visit www.abilify.com.

What are the ingredients in ABILIFY?

Active ingredient: aripiprazole

Inactive ingredients:

Tablets: cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake.

ABILIFY DISCMELT Orally Disintegrating Tablets: acesulfame potassium, aspartame (which contains phenylalanine), calcium silicate, croscarmellose sodium, crospovidone, crème de vanilla (natural and artificial flavors), magnesium stearate, microcrystalline cellulose, silicon dioxide, tartaric acid, and xylitol. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake.

ABILIFY Oral Solution: disodium edetate, fructose (200 mg per mL), glycerin, dl-lactic acid, methylparaben, propylene glycol, propylparaben, sodium hydroxide, sucrose (400 mg per mL), and purified water. The oral solution is flavored with natural orange cream and other natural flavors.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

ABILIFY is a trademark of Otsuka Pharmaceutical Company.

Source: http://packageinserts.bms.com/medguide/medguide_abilify.pdf

Related posts

• Antipsychotics (0)
• Your Drug May Be Your Problem (0)
• The Side Effects Of Common Psychiatric Drugs: Antipsychotics (0)
• Mental Health Medications (0)
• Child and Adolescent Mental Illness Statistics (0)
• The Side Effects Of Common Psychiatric Drugs: Psychostimulants (0)
• The Side Effects Of Common Psychiatric Drugs: Anti-Anxiety Drugs (0)
• Latuda (0)
• Cognitive Behavioral Therapy (0)
• Zyprexa (Olanzapine) (0)

How does Zeldox work? What will it do for me?

Ziprasidone belongs to the class of medications called antipsychotics. It is used to control the symptoms of schizophrenia and related mental health disorders. It works by adjusting the balance of chemicals in the brain that are involved in schizophrenia.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. As well, some forms of this medication may not be used for all of the conditions discussed here. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use Zeldox?

The usual starting dose of ziprasidone is 20 mg to 40 mg twice daily with food. The dose can be increased gradually every 2 days up to 80 mg twice daily, as recommended by the doctor. For maintenance treatment, the lowest dose needed to control symptoms should be used. The capsules should be swallowed whole with a glass of water.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to use this medication exactly as prescribed by your doctor. If you miss a dose of this medication by only a few hours, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

Store this medication at room temperature, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

What form(s) does Zeldox come in?

20 mg

Each size No. 4 blue/white opaque hard gelatin capsule, imprinted in black with “Pfizer” and “396″ or “ZDX 20″, contains ziprasidone hydrochloride, monohydrate equivalent to 20 mg of ziprasidone. Nonmedicinal ingredients: lactose monohydrate, pregelatinized starch, magnesium stearate.

40 mg

Each size No. 4 blue/blue opaque hard gelatin capsule, imprinted in black with “Pfizer” and “397″ or “ZDX 40″, contains ziprasidone hydrochloride, monohydrate equivalent to 40 mg of ziprasidone. Nonmedicinal ingredients: lactose monohydrate, pregelatinized starch, magnesium stearate.

60 mg

Each size No. 3 white/white opaque hard gelatin capsule, imprinted in black with “Pfizer” and “398″ or “ZDX 60″, contains ziprasidone hydrochloride, monohydrate equivalent to 60 mg of ziprasidone. Nonmedicinal ingredients: lactose monohydrate, pregelatinized starch, magnesium stearate.

80 mg

Each size No. 2 blue/white opaque hard gelatin capsule, imprinted in black with “Pfizer” and “399″ or “ZDX 80″, contains ziprasidone hydrochloride, monohydrate equivalent to 80 mg of ziprasidone. Nonmedicinal ingredients: lactose monohydrate, pregelatinized starch, magnesium stearate.

Some medications may have other generic brands available. Always ask your doctor or pharmacist about the safety of switching between brands of the same medication.

Who should NOT take Zeldox?

Ziprasidone should not be used by anyone who:

is allergic to ziprasidone or to any of the ingredients of the medication

is taking medications such as dofetilide, sotalol, quinidine, mesoridazine, thioridazine, chlorpromazine, droperidol, pimozide, sparfloxacin, gatifloxacin, moxifloxacin, halofantrine, mefloquine, pentamidine, arsenic trioxide, levomethadyl acetate, dolasetron mesylate, probucol, tacrolimus, or any other medication that can cause QT prolongation

has or has a history of QT prolongation (including congenital long QT syndrome)

has recently had a heart attack

has severe heart failure

What side effects are possible with Zeldox?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

abdominal pain

agitation

constipation

diarrhea

dizziness

drowsiness

dry mouth

fatigue

flu-like symptoms

fungal skin infections

heartburn

increased cough

increased sun sensitivity

leakage of fluid or milk from breasts (women)

loss of appetite  menstrual changes

muscle aches

muscle stiffness or spasm

nausea or upset stomach

rash

respiratory tract infections

restlessness

runny nose

sensations that the room is spinning

sexual difficulties

slowness of movement

tremor

vision changes

vomiting

weakness

weight gain

Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

abnormal movements of the face or tongue

abnormal walking

changes in body temperature, or feeling very hot and unable to cool down

chest pain

continuous erection

dizziness, especially when standing from a lying or seated position

high blood pressure

muscle twitching

painful eye movements

Stop taking the medication and seek immediate medical attention if any of the following occur:

abnormal heart rhythms (such as fast or slow heart rate, palpitations), fainting or seizures

confusion, reduced consciousness, high fever, or muscle stiffness

peeling or blistering skin

symptoms of a severe allergic reaction (itching, skin rash, shortness of breath, swelling of the face, lips, or tongue)

symptoms of a stoke such as sudden weakness or numbness of the face, arms, or legs (especially on one side); slurred speech; vision problems

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for Zeldox?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Abnormal heart rhythms: This medication can cause abnormal heart rhythms. Certain medications (e.g., sotalol, quinidine, thioridazine, chlorpromazine, droperidol, pimozide, gatifloxacin, moxifloxacin, mefloquine, pentamidine, arsenic trioxide, dolasetron mesylate, probucol, tacrolimus) can increase the risk of a type of abnormal heart rhythm called QT prolongation, and should not be used in combination with ziprasidone. You are more at risk for this type of abnormal heart rhythm and its complications if you:

are female

are older than 65 years of age

have a family history of sudden cardiac death

have a history of heart disease or abnormal hearth rhythms

have a slow heart rate

have congenital prolongation of the QT interval

have diabetes

have had a stroke

have low potassium, magnesium, or calcium levels

have nutritional deficiencies

Talk to your doctor about the risks and benefits of using this medication if you have any of these risk factors.

Blood sugar: This medication may cause high blood sugar levels. If you experience weakness, increased thirst, increased urination, and increased appetite while taking this medication, contact your doctor.

Body temperature: This medication, like other antipsychotic medications, can disrupt the body’s ability to control body temperature. People who exercise vigorously, who are exposed to extreme heat, are dehydrated, or are taking anticholinergic medications (e.g., benztropine, oxybutynin) are more at risk. Contact your doctor as soon as possible if you feel very hot and are unable to cool down while taking this medication.

Drowsiness/reduced alertness: Ziprasidone may interfere with activities requiring mental alertness. People taking this medication should not drive or operate machinery until they know how this medication affects them.

Low blood pressure: Ziprasidone may cause low blood pressure when rising from a sitting or lying position. If you feel dizzy, lightheaded, or feel your pulse racing, or if you faint, call your doctor. While you are taking this medication, get up slowly if you have been sitting or lying down for a prolonged period.

Neuroleptic malignant syndrome (NMS): Ziprasidone, like other antipsychotic medications, can cause a potentially fatal syndrome known as neuroleptic malignant syndrome (NMS). If you notice the symptoms of NMS such as high fever, muscle stiffness, confusion or loss of consciousness, sweating, racing or irregular heartbeat, or fainting, get immediate medical attention.

Seizures: Ziprasidone may increase the risk of seizures, especially in people who have had seizures in the past. People who are at risk of seizures who take this medication should be closely monitored by their doctor.

Tardive Dyskinesia (TD): TD, a syndrome consisting of potentially irreversible, involuntary, repetitive movements of the face and tongue muscles, may develop in people who take certain antipsychotic medications including ziprasidone. Although TD appears most commonly in seniors, especially women, it is impossible to predict who will develop TD. The risk of developing TD increases with higher doses and long-term treatment. If you experience muscle twitching or abnormal movements of the face or tongue, contact your doctor as soon as possible.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if ziprasidone passes into breast milk. It is recommended that women taking this medication should not breast-feed.

Children: The safety and effectiveness of using this medication have not been established for children less than 18 years of age.

Seniors: Medications similar to ziprasidone can increase the risk of death when used to treat seniors with dementia. Ziprasidone should not be used in seniors with dementia.

What other drugs could interact with Zeldox?

There may be an interaction between ziprasidone and any of the following:alcohol

amiodarone

arsenic trioxide

blood-pressure medications

carbamazepine

chlorpromazine

dolasetron mesylate

dopamine agonists (e.g., pramipexole, ropinirole)

droperidol

gatifloxacin

ketoconazole     levodopa

lithium

mefloquine

moxifloxacin

pentamidine

pimozide

probucol

procainamide

quinidine

sotalol

tacrolimus

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

stop taking one of the medications,

change one of the medications to another,

change how you are taking one or both of the medications, or

leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Related posts

• Antipsychotics (0)
• The Side Effects Of Common Psychiatric Drugs: Antipsychotics (0)
• Zyprexa (Olanzapine) (0)
• Zoloft – sertraline HCl (0)
• Your Drug May Be Your Problem (0)
• XEPLION® (paliperidone palmitate) (0)
• Valium (diazepam) (0)
• US Kids Represent Psychiatric Drug Goldmine (1)
• Schizophrenia (0)
• Schizophrenia (0)

The U.S. Food and Drug Administration today approved Latuda (lurasidone HCl) tablets for the treatment of adults with schizophrenia.

Schizophrenia affects about 1 percent of the U.S. population, ages 18 years and older, in a given year. The most prominent symptoms include hallucinations, delusions, disordered thinking and behavior, and suspiciousness. Hearing voices that other people don’t hear is the most common type of hallucination. These experiences can make people with the disorder fearful and withdrawn.

“Schizophrenia can be a devastating illness requiring lifelong treatment,” said Thomas Laughren, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “Some patients do not respond well to certain types of drug therapy, so it is important to have multiple treatment options available.”

Latuda is included in the atypical antipsychotic class of drugs. All atypical antipsychotics contain a boxed warning alerting prescribers to an increased risk of death associated with off-label use of these drugs to treat behavioral problems in older people with dementia-related psychosis. No drug in this class is approved to treat patients with dementia-related psychosis.

Four six-week controlled studies of adults with schizophrenia demonstrated the effectiveness and safety of Latuda. In the trials, patients treated with Latuda had fewer symptoms of schizophrenia than those taking an inactive pill (placebo).

The most common adverse reactions reported by those in clinical trials were drowsiness, feelings of restlessness and the urge to move (akathisia), nausea, movement abnormalities such as tremors, slow movement, or muscle stiffness (Parkinsonism), and agitation.

Latuda is manufactured by Sunovion Pharmaceuticals Inc. of Fort Lee, N.J.

Source: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm231512.htm

Related posts

• The Side Effects Of Common Psychiatric Drugs: Anti-Anxiety Drugs (0)
• Valium (diazepam) (0)
• The Side Effects Of Common Psychiatric Drugs: Newer Antidepressants (0)
• The Side Effects Of Common Psychiatric Drugs: Antipsychotics (0)
• The Side Effects Of Common Psychiatric Drugs: Psychostimulants (0)
• The Side Effects Of Common Psychiatric Drugs: Older Antidepressants (0)
• The Side Effects Of Common Psychiatric Drugs: Lithium (0)
• Zyprexa (Olanzapine) (0)
• XEPLION® (paliperidone palmitate) (0)
• DSM-IV for Schizophrenia (0)

Antipsychotics

What are antipsychotics used for?

Antipsychotics are usually used to help treat people with schizophrenia and similar conditions such as psychosis. They are also used to treat other problems such as mania, hypomania and mood disorders. Occasionally antipsychotics are used to help manage agitation or anxiety. Medicines are often used to treat more than one condition, so if you are not sure why you have been prescribed an antipsychotic, you should discuss this with your doctor.

Antipsychotics are classified into two groups, ‘typical’ or ‘first-generation’ antipsychotics and ‘atypical’ or ‘second generation’ antipsychotics. Examples of ‘typical antipsychotics’ include, haloperidol, chlorpromazine and flupentixol. Examples of ‘atypical antipsychotics’ include risperidone, olanzapine, clozapine and aripiprazole. The difference between the two groups includes the type and frequency of the side effects that they may cause.

What are the benefits of taking antipsychotics?

People with schizophrenia or psychosis may have a range of symptoms that are often thought of in two groups – ‘positive’ and ‘negative’ symptoms. Positive symptoms include hallucinations and delusions, which can include symptoms such as hearing voices, or experiencing ‘strange things’ such as seeing or feeling things that may not be real or having mistaken beliefs. People may also feel suspicious or paranoid, or feel that other people can read their thoughts. Negative symptoms are less noticeable than positive symptoms, and include tiredness, lack of concentration and lack of energy. People may become quite inactive and withdrawn from normal everyday activities.

Antipsychotics can help to treat some of these symptoms and keep them under control in the long term. Treating these symptoms should help people feel less confused, anxious and restless, and help them to think more clearly. This will help them to cope better with the stresses of everyday life, and help them to return to normal activities such as work or hobbies. Antipsychotics may also help people engage better with other kinds of therapies such as psychological treatments and therefore allow for a better response.

How quickly do antipsychotics work?

Antipsychotics work over a period of weeks. People may find that they feel calmer soon after starting treatment, but it may take several weeks until they have their full effect. Not everybody benefits from antipsychotics but most people do. If you do not feel any benefit or improvement in your symptoms after six to eight weeks, you should discuss this with your doctor or healthcare worker.

What are the usual doses of antipsychotics and how should I take them?

People will usually be started on a low dose, which will then slowly be increased to the usual effective dosage range for that medicine. Refer to the manufacturer’s patient information leaflet for the antipsychotic that you have been given. Do not change your dose of medication without checking with your doctor, as it can affect your response to the medication, or may be harmful.

What should I do if I miss a dose?

You will get the most out of your medication when taken correctly and regularly. If you miss, or forget a dose at your usual time, but remember within an hour or two take it straight away. If it is longer than this just leave out the missed dose and take the next dose at the usual time. Never take extra medication at the next dose. If you find it difficult to remember taking medication speak to your pharmacist or healthcare worker.

For how long should I take antipsychotics?

Your doctor will discuss with you how long you will need to take medication for, which will vary depending on the type of illness you have. Some people may need to take medication for a number of years and others need to stay on medication longer. Taking medication regularly may prevent you from becoming unwell. Your doctor should regularly review your medication to check whether you are experiencing any unwanted effects and make sure that your dose is still right for you. Stopping antipsychotics suddenly may cause ‘discontinuation symptoms’ such as jerky movements and nausea. Your original symptoms may also return after three to six months of stopping. The dose should usually be reduced gradually before stopping. Check with your doctor for advice about this. Antipsychotics are not addictive.

What are the side effects of antipsychotics?

As with all medicines there is a risk of unwanted effects (side effects). Some can occur soon after starting treatment so you may experience these before you feel better. Most are temporary and should go away after a few days or weeks. Not everyone will get side effects and people experience them to different degrees. If you feel that you have side effects that are causing you discomfort, discuss this with your doctor, pharmacist, nurse or healthcare worker. The table on the following page lists some of the main recognised side effects of antipsychotics but these will depend on the individual antipsychotic you are taking.

What about alcohol and ‘street’ drugs?

Both alcohol and antipsychotics can affect the brain so it is not recommended that you drink alcohol while taking antipsychotics. Drinking alcohol can make psychosis worse and in combination with antipsychotics can cause severe drowsiness. Once you are used to the medication and know the effects of taking alcohol you may be able to drink alcohol occasionally and in small amounts. It is good to be cautious because alcohol affects people in different ways, especially when taking medication.

Do not stop taking your medication because you feel like drinking alcohol. If you drink alcohol, drink only small amounts. Never drink alcohol and drive while taking medication.

‘Street’ drugs (for example, cannabis, ecstasy, speed, heroin and cocaine) can often also make psychosis worse. People taking ecstasy whilst on antipsychotics are more likely to experience movement disorders. There is very little information on taking antipsychotics with other ‘street’ drugs, so the effect and safety of doing this is unknown. It is best if you do not take ‘street’ drugs whilst taking antipsychotics. You may need to get advice and support to help you do this.

What about other medicines?

If you take any other medicines or herbal remedies including any that have been newly prescribed or bought, it is important to check with your doctor or pharmacist that they are safe with antipsychotics. You must take particular care when taking drugs that lower your blood pressure with antipsychotics.

When should I be cautious?

It is usually safe to take antipsychotics regularly, as prescribed by your doctor, but they are not suitable for everyone. If any of the following situations apply to you, you should tell your doctor immediately.

1 If you are allergic to antipsychotics (if you have taken it before and developed a rash, itching, swollen mouth or throat);

2 If you have diabetes, epilepsy (or have had a fit in the past), suffer from kidney disease, heart problems or have had a stroke;

3 If you have Parkinson’s disease or take any medicines usually used to treat this;

4 If you have an abnormal heart rate or take medicines to control your heart rate;

5 If you have ever had a history of breast cancer or a prolactin dependent tumour;

6 If you have phaeochromocytoma (a tumour of the adrenal gland);

7 If you are pregnant, or are planning to become pregnant; or

8 If you are breastfeeding.

Please refer to the manufacturer’s patient information leaflet that comes with your medicine for more information and the full list of side effects and precautions. If you have any questions or concerns about your medicines, or if you are worried about anything you think might be a side effect, ask your doctor, pharmacist or nurse.

This leaflet gives you some information about this medicine. It does not replace the expertise or judgement of a doctor, pharmacist or other healthcare professional. It is not a manufacturer’s patient information leaflet and is not to be taken as a substitute for, or an endorsement of, the manufacturer’s information or advice in respect of any medicine referred to in this leaflet. You might find more information in other leaflets or books, or on the internet but remember, the internet is not always accurate.

Whilst every care has been taken in the compilation of this leaflet, CNWL is not responsible for any loss or damage howsoever caused as a result of any inaccuracy or error contained in this leaflet, including (for the avoidance of doubt) in relation to breach of contract, misrepresentation or negligence whether of CNWL or any other person; but nothing in this leaflet shall exclude or restrict liability for death or personal injury resulting from negligence.

The information given in this leaflet is current as at the publication date.

This leaflet has been written by Central and North West London Mental Health NHS Trust Pharmacy Department, 30 Eastbourne Terrace, London W2 6LA www.cnwl.org – Publication Date: May 2007

Source: http://beh.zedcore.com

Related posts

• Abilify® Medication Guide (0)
• Zeldox (ziprasidone) (0)
• Your Drug May Be Your Problem (0)
• XEPLION® (paliperidone palmitate) (0)
• The Side Effects Of Common Psychiatric Drugs: Psychostimulants (0)
• The Side Effects Of Common Psychiatric Drugs: Antipsychotics (0)
• Antipsychotic Drugs (0)
• Zyprexa (Olanzapine) (0)
• What medications are used to treat schizophrenia? (0)
• Valium (diazepam) (0)

(Called Major Tranquilizers or Neuroleptics)

Brand Names (Generic Names):

Older Antipsychotics

Compazine (prochlorperazine)

Haldol (haloperidol)

Largactil (clorpromazine)

Lidone (molindone)

Loxitane (loxapine)

Mellaril (thioridazine hydrochloride)

Moban (molindone hydrochloride)

Navane (thiorixene)

Novo-Trifluzine (trifluoperazine)

Nozinan (methotrimeprazine)

Orap (pimozide)

Permitil (fluphenazine)

Phenergam (promethazie)

Proketazine (carphenazine)

Prolixin (fluphenazine hydrochloride)

Repoise (butaperazine Maleate)

Serentil (mesoridazine besylate)

Sparine (promazine)

Stelazine (trifluoperazine)

Stemetil (prochlorperazine)

Taractan (chlorprothixene)

Thorazine (chlorpromazine)

Tindal (acetophenazine)

Trancopal (chlormezanone)

Trilafon (perphenazine)

Vesprin (triflupromazine)

Newer Atypical Antipsychotics

Abilify (aripiprazole)

Clozaril (clozapine)

Geodon (ziprasidone hydrochloride)

Invega (palperidone)

Leponex (clozapine)

Risperdal (risperidone)

Serlect (sertindole)

Seroquel (quetiapine)

Symbyax (fluoxetine and olanzapine –antidepressant/antipsychotic mix)

Zeldox (ziprasidone)

Zyprexa (olanzapine)

Side Effects:

Abnormal gait (manner of walking)

Agitation

Akathisia*

Anxiety

Birth defects

Blood disorders

Blood-sugar abnormalities

Blurred vision

Breastmilk production

Cardiac arrest

Changes in behavior

Chest pain

Confusion

Constipation

Death from liver failure

Decreased sexual interest or ability

Depression

Diabetes

Diarrhea

Difficulty breathing, swallowing or fast

breathing

Difficulty falling asleep or staying asleep

Difficulty urinating or loss of bladder control

Dizziness

Dreaming more than usual

Drowsiness

Dry mouth

Dry or discolored skin

Excess sweating

Excessive weight gain

Extreme inner anxiety

Eye pain or discoloration

Fainting

Fast, irregular, or pounding

heartbeat

Fatal blood clots

Fever

Fine worm-like tongue movements

Flu-like symptoms

Headache

Heart arrhythmia

Heart failure

Heart palpitation

Heartburn

Heat stroke

Hemorrhage

High fever

Hives

Hostility

Hyperglycemia (abnormally high blood sugar)

Hypoglycemia (abnormally low blood sugar)

Impotence

Increased appetite

Increased salivation

Indigestion

Insomnia

Involuntary movements

Itching

Jaw, neck, and back muscle spasms

Joint pain

Lack of energy

Light-headedness

Loss of appetite

Manic reaction

Mood changes

Muscle or joint stiffness, pain, or weakness

Muscle twitching

Nausea

Nervousness

Neuroleptic Malignant Syndrome*

Nightmares

Pacing

Pain in arms, legs, back, or joints

Pain in the upper right part of the stomach

Painful erection that lasts for hours

Painful skin rashes

Pancreatitis (inflammation of pancreas, a gland near the stomach that helps digestion)

Poor concentration

Restlessness or pacing

Seizures or convulsions

Sexual dysfunction

Shakiness

Shaking hands that you cannot control

Sleepiness

Slow or difficult speech

Slow, jerky movements

Sore throat

Spasms

Suicidal thoughts

Swelling of the arms, hands, feet, ankles, or lower legs

Swollen and leaking breasts

Tachycardia (heart irregularity)

Tardive Dyskinesia*

Tremors

Unusual behavior

Unusual bleeding or bruising

Unusual tiredness

Violence

Vomiting

Weakness

Weight gain

Yellowing of the skin or eyes86

GENERAL WARNINGS AND STUDIES ON ANTIPSYCHOTICS:

2001: The Journal of Toxicology reported that the newer antipsychotics “will soon account for the majority of poisonings from antipsychotic agents that get presented to health care facilities in the U.S.”90 Researchers found, “[T]he ingestion of a single tablet of clozapine (Clozaril), olanzapine (Zyprexa) and risperidone (Risperidal) may cause significant toxicity in a toddler. Ataxia (involuntary muscular movement), confusions, EPS (extrapyramidal symptoms – nerve damage), coma and respiratory arrest have been reported following ingestion of 50-200 mg of clozapine in toddlers.”91

September 2003: The FDA requested the makers of six newer antipsychotic drugs add a caution to their labeling language about the potential risk of diabetes and blood sugar abnormalities.92

June 2004: The Australian Therapeutic Goods Administration published an Adverse Drug Reactions Bulletin reporting that the newer antipsychotics could increase the risk of diabetes.93

September 22, 2005: Dr. Jeffrey Lieberman of Columbia University and other researchers published a study in The New England Journal of Medicine that compared the older generation of antipsychotics with several newer ones. Far from proving effectiveness, of the 1,493 patients who participated, 74% discontinued taking antipsychotic drugs before the end of their treatment due to inefficacy, intolerable side effects or other reasons. After 18 months of taking Zyprexa, 64% of the patients stopped taking it—most commonly because it caused sleepiness, weight gain or neurological symptoms like stiffness and tremors.94

December 1, 2005: Researchers found that 18% of nearly 23,000 elderly patients taking the older antipsychotics died within the first six months of taking them.95

May 2, 2006: USA Today released the results of an analysis of FDA data that showed at least 45 children died between 2000 and 2004 from the side effects of antipsychotic drugs (Clozaril, Risperdal, Zyprexa, Seroquel, Abilify and Geodon). Despite an adults-only FDA approval for these drugs, according to USA Today, up to 2.5 million children were prescribed them. As the FDA’s Adverse Drug Reactions reporting database only collects 1% to 10% of drug-induced side effects and reported deaths, the true child death rate could be between 450 and several thousand. Further, there were 1,328 reports of other side effects, some life-threatening, such as convulsions and low white blood cell count.96

January 5, 2008: The Lancet (Britain) published a study where the authors concluded “that the routine prescription of antipsychotic drugs early in the management of aggressive challenging behavior, even in low doses, should no longer be regarded as a satisfactory form of care.”97

April 2008: The American Geriatrics Society published a study entitled, “Antipsychotic Drug Use and Risk of Pneumonia in Elderly People,” which reviewed 22,944 elderly people with at least one antipsychotic prescription. The results of the study showed that “antipsychotics were associated with an almost 60% increase in the risk of pneumonia…” concluding that elderly people are at greater risk of pneumonia, especially during the first week of antipsychotic drug treatment.98

April 9, 2008: Pharmacoepidemiology and Drug Safety published a study entitled, “The use of central nervous system [CNS] drugs and analgesics [painkillers] among very old people with and without dementia.” The study compared the use of CNS drugs in people aged 85 years or older, with and without dementia and concluded: “[T]he use of antipsychotics in people with dementia should arouse particular concern, because of the high risk of severe adverse events and the limited evidence of positive effects.”99

May 26, 2008: The Archives of Internal Medicine published a study about “Antipsychotic

Therapy and Short-term Serious Events in Older Adults With Dementia” that found:

“Serious events…are frequent following the short-term use of antipsychotic drugs in

older adults with dementia. Antipsychotic drugs should be used with caution even when

short-term therapy is being prescribed.”100

June 2008: The FDA issued a warning to healthcare professionals that conventional and

atypical antipsychotics are associated with an increased risk of mortality in elderly patients

treated for dementia-related psychosis. It specified that antipsychotics are not indicated

for the treatment of this condition. Additionally, the FDA required the manufacturers of

these drugs to add a boxed warning about this risk to the prescribing information. Older,

conventional antipsychotics were also to carry a “black box” warning about an increased

risk of death in some elderly people.101

April 2009: The Irish Medicines Board published in their Drug Safety Newsletter, a warning

about antipsychotics causing a risk of stroke and now increased risk of mortality in elderly

patients treated for dementia. This risk covers both typical and atypical antipsychotics.102

WARNINGS ON SPECIFIC ANTIPSYCHOTICS:

ABILIFY (aripiprazole):

Abilify and other antipsychotic drugs have caused a potentially fatal condition called

neuroleptic malignant syndrome. Patients who develop this may have high fevers, muscle

rigidity, altered mental status, irregular pulse or blood pressure, rapid heart rate, excessive

sweating, and heart arrhythmias (irregularities).103

Body temperature regulation—disruption of the body’s ability to reduce core body

temperature—has been attributed to antipsychotic agents such as Abilify.104

April 2003: The U.S. consumer advocacy group Public Citizen conducted a review of

information published on Abilify, basing their evaluation primarily on publicly available

FDA reviews of information submitted by the manufacturer to gain FDA approval for

Abilify. Approval was based on five trials only lasting four to six weeks. According to

Public Citizen, “…nothing in these five trials can lead one to believe that aripiprazole

(Abilify) is a meaningful advancement in the treatment of schizophrenia.”105

The information insert on Abilify lists hyperglycemia (abnormally high blood sugar—

usually associated with diabetes), hypoglycemia (abnormally low blood sugar) and diabetes

as possible side effects.106

Clozaril (clozapine):

May 2008: Medsafe (New Zealand) posted a prescriber update called “Clozapine and

Achy Breaky Hearts” warning that clozapine can cause myocarditis [inflammation of the

heart muscle] that may be fatal. It was also associated with cardiomyopathy [disease of

the heart muscle]. While risk factors are unknown, pre-treatment cardiovascular screening

was recommended.107

May 2008: Medsafe posted their June 2008 “Watching Briefs,” a report in which they

included a warning: “Use of clozapine in older patients carries a higher risk of adverse

reactions such as postural hypotension [low blood pressure], falls, sedation and constipation,

compared to use in younger patients. Therefore, increased clinical monitoring of the elderly

is necessary to ensure their safety.”108

Haldol (haloperidol):

September 17, 2007: The FDA issued an alert to Healthcare Professionals about

haloperidol (marketed as Haldol), stating: “Due to a number of case reports of sudden

death, TdP [Torsades de Pointes] and QT prolongation [TdP and QT prolongation are types

of heart abnormalities] in patients treated with haloperidol (especially when the drug is

given intravenously or at doses higher than recommended), the sponsor has updated the

labeling for haloperidol.” ECG (Electrocardiogram—a graphical recording of the cardiac

cycle produced by a special machine, a.k.a. EKG) monitoring was recommended if

haloperidol is given intravenously, even though haloperidol is not approved for intravenous

administration.109

ZYPREXA (olanzapine):

July 22, 2005: Eli Lilly & Co., the manufacturer of Zyprexa, agreed to pay $1.07 billion

to settle more than 8,000 claims against the drug, alleging it could potentially cause lifethreatening

diabetes.110

September 22, 2005: Dr. Jeffrey Lieberman of Columbia University and other researchers

published a study in The New England Journal of Medicine comparing an older generation

of antipsychotics with several newer ones.111 After 18 months of taking Zyprexa, 64%

of the patients stopped taking it, most often because it was not well tolerated and caused

sleepiness, weight gain or neurological symptoms like stiffness and tremors.112

October 5, 2007: Eli Lilly issued an important Safety Information update on its website

and product labels for Zyprexa and Symbyax (combination of Zyprexa and fluoxetine, or

Prozac) warning of the risk of weight gain, hyperglycemia (increased blood sugar) and

hyperlipidemia (elevated fats in the blood and cholesterol).113

2008: The current Zyprexa Safety Information includes a “black box” warning of increased

risk of death in elderly patients with dementia, as well as the following warnings: High

level of fats in the blood, weight gain, high blood sugar, strokes and “mini strokes” (in

elderly people with dementia), neuroleptic malignant syndrome, tardive dyskinesia, low

blood pressure, trouble with judgment, thinking, and reflexes, trouble swallowing, body

temperature problems…and “this is not a complete list….”114

*Akathisia: A, meaning “without” and kathisia, meaning “sitting,” an inability to keep still. Patients

pace about uncontrollably. The side effect has been linked to assaultive, violent behavior.87

*Neuroleptic malignant syndrome: A potentially fatal toxic reaction where patients break into

fevers and become confused, agitated and extremely rigid. An estimated 100,000 Americans have

died from it after taking the older antipsychotics.88

*Tardive Dyskinesia: Tardive, meaning “late” and dyskinesia meaning, “abnormal movement of

muscles.” Tardive Dyskinesia is a permanent impairment of the power of voluntary movement of

the lips, tongue, jaw, fingers, toes and other body parts.89

References

1 Physicians’ Desk Reference, http://www.pdrhealth.com; “Adderall,” DrugStore.com, Internet URL: http://www.drugstore.com;

“Study Suggests Focalin (TM) LA Capsules (d-MPH-ER) Are Safe and Effective for ADHD in Adults,” PR Newswire, 5 May 2004;

A.D.D. Warehouse website; ADHDHelp, Internet URL: http://www.adhdhelp.org/metadate.htm. Journal of the Royal Society of Med.,

Vol 92, Mar. 99 “letters to the editor” p. 156. Medline Plus, www.nim.nih.gov/medlineplus: Millichap, J.Gordon “Methylphenidate

Role in Tourettes Syndrome Prevalence.

2 Diagnostic and Statistical Manual of Mental Disorders (DSM-III-R), American Psychiatric Association, Washington, D.C., 1987, p. 136.

3 “Drug Scheduling,” U.S. Drug Enforcement Administration Online, Internet URL: http://www.dea.gov.

4 Raul R. Gainetdinov; William C. Wetsel; Edward D. Sara; R. Levin Jones; Mohamed Jaber; Marc G. Caron, “Role of Serotonin in the

Paradoxical Calming Effect of Psychostimulants on Hyperactivity,” Science, 15 Jan. 1999.

5 “Statement on Concerta and Methylphenidate,” Statement posted on the FDA website, 28 June 2005.

6 Marian S. MacDonagh, PharmaD, and Kim Peterson, MS, “Drug Class Review on Pharmacologic Treatment for ADHD: Final

Report,” Oregon Health and Science University, Sept. 2005, pp. 13-20.

7 “FDA will study safety of attention-deficit drugs,” Kansas City Star, 5 Jan. 2006.

8 “Stimulants in children with ADHD may have negative CV effect,” Mental Health Law Weekly, 4 Feb. 2006.

9 Ricardo Alonso-Zaldivar, “Warning Urged for ADHD Drugs,” Los Angeles Times, 10 Feb. 2006.

10 Todd Zwillich, “FDA Panel Recommends Warnings of Rare Reports of Aggressive Behavior or Psychotic Symptoms,” WebMD, 23

Mar. 2006.

11 “Dark side of a wonder drug,” The Australian, 28 Mar. 2006.

12 Almut G. Winterstein, et al., “Cardiac Safety of Central Nervous System Stimulants in Children and Adolescents With Attention-

Deficit/Hyperactivity Disorder,” Pediatrics, Vol. 120, Dec. 2007, pp. e1494-e1501.

13 W. Goldman, et al., “Association between treatment with central nervous system stimulants and Raynaud’s Syndrome in children: a

study of rheumatology patients,” Arthritis & Rheumatism, Vol. 58, No. l, 2 Feb. 2008, pp. 563-566.

14 Brian Vastig, “Pay Attention: Ritalin Acts Much Like Cocaine,” JAMA, 22/29 Aug. 2001, Vol. 286, No. 8, p. 905.

15 Joel Turtel, Public Schools, Public Menace: How Public Schools Lie to Parents and Betray Our Children, (Library Books, New

York), 2004-2005, p. 135.

16 “Partnership Attitude Tracking Study” of teens in 2004, 17th Annual report by Partnership for a Drug-Free America, 21 Apr. 2005;

“Survey: 1 in 5 teens getting high on medications, over-counter drugs,” NewsItem.com, 2 May 2005.

17 Larry A. Kroutil, et al., “Nonmedical use of prescription stimulants in the United States,” Drug and Alcohol Dependence, Feb. 2006.

18 Brian Witte, “Slaying blamed on reaction to hyperactivity drug,” Associated Press, 25 Oct. 1999.

19 “J & J Psychiatric Safety Labeling, Cardiovascular Events Are Topic For Cmte,” FDAAdvisoryCommittee.com, June 2005.

20 “Health Canada Suspends Marketing of Adderall,” FDA Alert, 9 Feb. 2005.

21 “Health Canada allows Adderall XR® back on the Canadian market,” Health Canada News Release, 24 Aug. 2005.

22 Partnership Attitude Tracking Study, Teens – 2004, Partnership for a Drug-Free America, 21 Apr. 2005, p. 7; “Cylert recall

demanded over safety concerns,” Lifestyle News, www.mynippon.com/news/2005/03/cylert-recall-demanded-over-safety-concerns.

23 “Injured by Cylert?” Parker Waichman Alonso, LLP, http://www.yourlawyer.com/topics/overview/cylert.

24 “FDA Withdraws Approval for ADD Drug,” Associated Press, 24 Oct. 2005.

25 “Updated Safety Information: Warnings regarding serious rash, including Stevens-Johnson Syndrome and hypersensitivity reactions,

and psychiatric symptoms,” Cephalon, Inc., Sept. 2007.

26 Op. cit., DSM-III-R, pp. 136, 175.; Medical Economics Company, Physicians Desk Reference (Montvale, NJ: Medical Economics

Co, 1998), pp. 1,897.

27 “Methylphenidate (A Background Paper),” U.S. Drug Enforcement Administration, Oct. 1995, p. 16.

28 “Antidepressant Ritalin to be delisted because of abuse,” Daily Yomiuri Online, 19 Oct. 2007.

29 Ritalin Drug Label, fda.gov.

30 Physicians’ Desk Reference, http://www.pdrhealth.com; Joseph Glenmullen, M.D. Prozac Backlash, (Simon & Schuster, New York,

2000), p. 8; “Antidepressants Lift Clouds, But Lost ‘Miracle Drug’ Label,” The New York Times, 30 June 2002; Alice Park, “More

Drugs To Treat Hyperactivity,” TIME Magazine, 10 Sept. 2001; Wellbutrin/Bupropion, Prozac Truth website; “Teen Suffers Seizure

After Snorting Antidepressant,” HealthScoutNews Reporter, 23 Apr. 2003.

31 Dr. Candace B. Pert, Letter to the Editor, TIME Magazine, 20 Oct. 1997, p. 8.

32 “Worsening Depression and Suicidality in Patients Being Treated with Antidepressant Medication,” FDA Public Health Advisory, 22

Mar. 2004.

33 Gardiner Harris, “Antidepressant Study Seen to Back Expert,” The New York Times, 20 Aug. 2004.

34 “Antidepressant aggression concern,” BBC News Online, 21 Sept. 2004.

35 “Suicidality in Children and Adolescents Being Treated With Antidepressant Medications,” FDA Public Health Advisory, 15 Oct. 2004.

36 “New advice on prescribing anti-depressants,” New Zealand Ministry of Health Media Release, 21 Oct. 2004.

37 “Use of SSRI antidepressants in children and adolescents,” Australian Adverse Drug Reactions Bulletin, Vol. 23, No. 6, Dec. 2004.

38 “European Medicines Agency finalises review of antidepressants in children and adolescents,” European Medicines Agency Press

Release, 25 Apr. 2005.

39 Sarah Boseley, “Suicide fear from antidepressants,” The Guardian (London), 18 Feb. 2005.

40 Joanna Moncrieff and Irving Kirsch, “Efficacy of Antidepressants in Adults,” British Medical Journal, Vol. 331, 16 July 2005, pp.

155-157; Salynn Boyles, “Battle Brews Over Antidepressant Use,” Fox News, 15 Jul. 2005.

41 “Suicidality with SSRIs: adults and children,” Australian Adverse Drug Reactions Bulletin, Vol. 24, No. 4, Aug. 2005.

42 “Annex II,” Commission Decision of 19-VIII-2005, Commission of the European Communities, 19 Aug. 2005.

43 Ivar Aursnes, et al., “Suicide Attempts in Clinical Trials with Paroxetine Randomised Against Placebo,” BMC Medicine, Vol. 3, pp.

14-18.

44 Sheryl Ubelacker, “SSRI antidepressants may raise suicide risk in elderly patients: study,” Sympatico, 1 May 2006.

45 “Antidepressants should list new risks: FDA,” Reuters, 19 July 2006; “Combined Use of 5-Hydroxytryptamine Receptor Agonists (Triptans), Selective Serotonin Reuptake Inhibitors (SSRIs) or Selective Serotonin/Norepinephrine Reuptake Inhibitors (SNRIs) May

Result in Life-threatening Serotonin Syndrome,” FDA Public Health Advisory, 19 July 2006.

46 “FDA Proposes New Warnings About Suicidal Thinking, Behavior in Young Adults Who Take Antidepressants,” FDA News, 2 May 2007.

47 “Antidepressants and suicidal thoughts and behaviour,” Pharmacovigilance Working Party, Jan. 2008.

48 Yan Chen, et al., “Risk of Cerebrovascular Events [CVE] Associated with Antidepressant Use in Patients with Depression: A

Population-Bases, Nested Case-Control Study,” The Annals of Pharmacotherapy, Vol. 42, No. 2, pp. 177-184, 22 Jan. 2008.

49 “Implementation of warnings on suicidal thoughts and behaviour in antidepressants,” MHRA, 5 February 2008.

50 Irving Kirsch, et al., “Initial Severity and Antidepressant Benefits: A Meta-Analysis of Data Submitted to the Food and Drug

Administration,” Public Library of Science, Vol. 5, Iss. 2, 26 Feb. 2008.

51 “Antidepressant drug use and risk of venous thromboembolism,” Pharmacotherapy, Vol. 28, No. 2, 28 Feb. 2008.

52 Thomas Laughren, M.D., Letter to GlaxoSmithKline Attn: Randal L. Batenhorst, Food and Drug Administration, Jan. 2009.

53 Benedict Carey, “Treatment of Depression in Pregnancy Affects Babies,” The New York Times, 4 Feb. 2005.

54 “General information concerning use of SSRI antidepressants in pregnant women,” Therapeutic Goods Administration, 7 Sept. 2005.

55 “Paroxetine HCL – Paxil and generic paroxetine,” 2005 Safety Alerts for Drugs, Biologics, Medical Devices, and Dietary

Supplements, FDA MedWatch, 27 Sept. 2005.

56 Steve Mitchell, “Analysis: SSRIs’ risk to infants,” United Press International, 6 Feb. 2006.

57 “Advisory – Newer antidepressants linked to serious lung disorder in newborns,” Health Canada press release, 10 Mar. 2006.

58 Maria Bishop, “Use of Antidepressants in Pregnancy Affects Neonatal Outcomes: Presented at AACAP,” Doctor’s Guide, 29 Oct.

2007.

59 “Paxil, Prozac, Zoloft and Other SSRI Antidepressants Tied to Premature Birth,” News Inferno, 6 May 2008.

60 “Duloxetine hydrochloride (marketed as Cymbalta) information,” FDA information sheet, 30 June 2005.

61 “Cymbalta (duloxetine hydrochloride),” 2005 Safety Alerts for Drugs, Biologics, Medical Devices, and Dietary Supplements, FDA

MedWatch, 17 Oct. 2005.

62 “NDA # 21-733. CYMBALTA® (duloxetine hydrochloride) Delayed-release Capsules. MACMIS # 14550,” FDA, 2 Oct. 2007.

63 “Paroxetine,” FDA Public Health Advisory, 8 Dec. 2005.

64 Benedict Carey and Gardiner Harris, “Antidepressant May Raise Suicide Risk,” The New York Times, 12 May 2006.

65 Corrado Barbui, M.D., et al., “Effectiveness of paroxetine in the treatment of acute major depression in adults: a systematic reexamination

of published and unpublished data from randomized trials,” Canadian Medical Association Journal, Vol. 178, No. 3, 29

Jan. 2008.

66 “New Warning for Strattera,” FDA Talk Paper, 17 Dec. 2004.

67 “Attention Drug to Get New Warning,” Los Angeles Times, 18 Dec. 2004.

68 “Strattera to Get New Risk Label,” The Washington Post, 18 Dec. 2004.

69 “New Drugs in Pipeline,” Psychiatric News, 21 Dec. 2001.

70 “Lilly to add suicide warning to Strattera,” ABC News, 29 Sept. 2005.

71 “Atomoxetine and suicidal behavior: update,” Canadian Adverse Reaction Newsletter, Vol. 18, Iss. 3, July 2008.

72 “Atomoxetine: risk of psychotic or manic symptoms,” Drug Safety Update, MHRA, Vol. 2, Iss. 8, March 2009.

73 “Teen Suffers Seizure After Snorting Antidepressant,” HealthScoutNews Reporter, 23 Apr., 2003.

74 Op. cit., Prozac Truth website.

75 Alice Park, “More Drugs To Treat Hyperactivity,” TIME Magazine, 10 Sept. 2001.

76 Op. cit., Prozac Truth website.

77HealthScoutNews Reporter.

78 Op. cit. Physicians’ Desk Reference, http://www.pdrhealth.com.

79 “Suicidality in Children and Adolescents Being Treated With Antidepressant Medications,” FDA Public Health Advisory, 15 Oct.

2004.

80 Op cit.New Zealand Ministry of Health.

81 Italian Official Gazette, No. 224, 26 Sept. 2005.

82 “Depression in Children and Young People,” National Institute for Health and Clinical Excellence, Sept. 2005, pp. 16, 18 and 28.

83 FDA, “Antidepressant Use in Children, Adolescents, and Adults,” www.fda.gov/CDER/Drug/antidepressants?default.html, updated

2 May 2007.

84 Op. Cit.Maria Bishop.

85 “Antidepressant drug use and risk of venous thromboembolism,” Pharmacotherapy, Vol. 28, No. 2, 28 Feb. 2008.

86 Physicians’ Desk Reference, http://www.pdrhealth.com; “ABILIFY Rx Only (aripiprazole) Tablets,” Package Insert, revised Mar.

2004; “GENERIC NAME: Aripiprazole BRAND NAME: Abilify,” Internet URL: http://www.MedicineNet.com, Last Editorial

Review: 9/8/04; “Aripiprazole Brand Name: Abilify,” Internet URL: http://www.HealthyPlace.com, Ty C. Colbert, Rape of the Soul,

How the Chemical Imbalance Model of Modern Psychiatry has Failed its Patients, (Kevco Publishing, California, 2001), p. 106.

87 Robert Whitaker, Mad in America: Bad Science, Bad Medicine, and the Enduring Mistreatment of the Mentally Ill, (Perseus

Publishing, New York, 2002), pp. 182, 186.

88 Op. cit., Robert Whitaker, p. 208.

89 George Crane, “Tardive Dyskinesia in Patients Treated with Major Neuroleptics: A Review of the Literature,” American Journal of

Psychiatry, Vol. 124, Supplement, 1968, pp. 40-47.

90 Michael J. Burns, “The Pharmacology and Toxicology of Atypical Antipsychotic Agents,” Journal of Toxicology, 1 Jan. 2001.

91 Ibid.

92 “FDA: Antipsychotic Drugs, Diabetes Linked,” Associated Press Online, 18 Sept. 2003.

93 “Atypical antipsychotics and hyperglycaemia,” Australian Adverse Drug Reactions Bulletin, Vol. 23, No. 3, June 2004.

94 Jeffrey A. Lieberman, M.D., et al., “Effectiveness of Antipsychotic Drugs in Patients with Chronic Schizophrenia,” The New England Journal of Medicine, Vol. 353, No. 12, 22 Sept. 2005.

95 Philip S. Wang, et al., “Risk of Death in Elderly Users of Conventional vs. Atypical Antipsychotic Medication,” The New England

Journal of Medicine, Vol. 353, No. 22, 1 Dec. 2005.

96 Marilyn Elias, “New antipsychotic drugs carry risks for children; Side effects can lead to bigger health problems,” USA Today, 2

May 2006.

97 Peter Tyrer, et al., “Risperidone, haloperidol, and placebo in the treatment of aggressive challenging behaviour in patients with

intellectual disability: a randomized controlled trial,” The Lancet, Vol. 371, 5 Jan. 2008.

98 Wilma Knol, M.D., et al., “Antipsychotic Drug Use and Risk of Pneumonia in Elderly People,” The American Geriatrics Society, Vol.

56, No. 4, pp. 661-666, Apr. 2008.80

99 Hugo Lovheim, M.D., Stig Karlsoon, R.N., Ph.D., et al., “The use of central nervous system drugs and analgesics among very old

people with and without dementia,” Pharmacoepidemiology and Drug Safety, 9 Apr. 2008.

100 Paula A. Rochon, M.D., MPH, FRCPC, et al., “Antipsychotic Therapy and Short-term Serious Events in Older Adults With

Dementia,” The Archives of Internal Medicine, Vol. 168, No. 10, 26 May 2008.

101 “Information for Healthcare Professionals Antipsychotics,” FDA, June 2008; “US FDA expands antipsychotic drug warning,”

Reuters UK, 17 June 2008.

102 “Update on the safety of antipsychotic medicines – risk of stroke and increased risk of mortality in elderly patients treated for

dementia,” Drug Safety Newsletter, Iss. 30, Apr. 2009, p. 5.

103 MedicineNet.com, Last Editorial Review: 9/8/04.

104 “Abilify Information,” Pharma-Help.com.

105 “The New Anti-Psychotic Drug Aripiprazole (ABILIFY),” Public Citizen’s eLetter, Apr. 2003.

106 Op. cit., “ABILIFY Rx Only (aripiprazole) Tablets,”

107 “Clozapine and Achy Breaky Hearts,” MedSafe, May 2008.

108 Watching Briefs, MedSafe, June 2008.

109 “Information for Healthcare Professionals Haloperidol (marketed as Haldol, Haldol Decanoate and Haldol Lactate),” FDA ALERT,

17 Sept. 2007.

110 Jeff Swiatek, “Uncertainty was Driver in Zyprexa Deal,” IndianapolisStar.com, 11 June 2005.

111 Op. cit., Jeffrey A. Lieberman, M.D., et al.

112 “Study: New drugs little better for schizophrenia,” St. Petersburg Times, 20 Sept. 2005.

113 “Important Safety Information about ZYPREXA® (olanzapine),” Eli Lilly and Company, 5 Oct. 2007; “Lilly Announces Updates

to the Zyprexa and Symbyax U.S. Labels,” PRNewswire, Bio-Medicine, 5 Oct. 2007.

114 ZYPREXA Safety Information, www.zyprexa.com.

115 Physicians’ Desk Reference, http://www.pdrhealth.com.

116 Tracey McVeigh, “Tranquilizers ‘more lethal than heroin,’” The Observer, 5 Nov. 2000.

117 Matt Clark, Mary Hager, “Valium Abuse: The Yellow Peril,” Newsweek, 24 Sept. 1979; Dr. Patrick Holford, “How to Quit

Tranquilizers,” www.patrickholdford.com, 2008.

118 Ibid.

119 Op. cit., Tracey McVeigh.

120 “Elderly On Long-Acting Anxiety, Insomnia Drugs Have More Car Crashes,” Doctor’s Guide citing Journal of American Medical

Association, 30 June 1997.

121 “Agression, Violence & Bezodiazapines,” Benzo.org.uk, citing British National Formulary, 2001.

122 Benzo.org.uk, citing Professor C. Heather Ashton, Benzodiazepines: How They Work and How To Withdraw, Feb. 2001.

123 “The Influence on the Pharmaceutical Industry,” House of Commons, UK, Health Committee, Vol. 1, Mar. 2005. p. 65.

124 Tarja-Brita R. Wahlin, et al., “Falls and fall risk among nursing home residents,” The Journal of Clinical Nursing, Vol. 17, pp. 126-

134, Jan. 2008.

125 “Europe-wide review recommends updates to product information for varenicline (brand name Champix),” MHRA, 14 Dec. 2008.

126 “Early Communication About an Ongoing Safety Review Varenicline (marketed as Chantix),” FDA, 20 Nov. 2007.

127 “Varenicline (marketed as Chantix) Information,” FDA Alert, 1 Feb. 2008.

128 Op. cit., House of Commons, UK, Health Committee, p. 65.

129 Anna Maria Dademan, “Flunitrazepam and violence—psychiatric and legal issues,” Department of Clinical Neuroscience,

Occupational Therapy and Elderly Care, Research Division of Forensic Psychiatry, Karolinska Institute, Sweden, 2000, p. 43.

130 “Zolpidem (‘Stilnox’) – Updated information – February 2008,” Theraputic Goods Administration, 21 Feb. 2008; “Club Drugs: An

Update,” Drug Intelligence Brief, Drug Enforcement Administration, Sept. 2001.

131 “FDA Safety Changes: Ambien, Primazin IM/IV, Hepsera,” Medscape, 28 Aug. 2008.

132 Peter Breggin, Toxic Psychiatry, (St. Martin’s Press, New York, 1991) p. 245.

133 Jerrold F. Rosenbaum, et al., “Emergence of Hostility During Alprazolam Treatment in Borderline Personality Disorder,” The

American Journal of Psychiatry, Vol. 141, No. 6 (June 1984), pp. 792-793.

134 David L. Gardner and Rex W. Cowdrey, “Alprazolam-Induced Dyscontrol in Borderline Personality Disorder,” The American

Journal of Psychiatry, Vol. 142, No. 1 (Jan. 1985), pp. 98-100.

135 “Xanax addiction extremely tough to kick,” MSNBC News Online, 2001.

136 Statement by Joseph A. Califano, Jr., Chairman and President, “Under the Counter: The Diversion and Abuse of Controlled

Prescription Drugs in the U.S.” The National Center on Addiction and Substance Abuse at Columbia University, July 2005.

137 Physicians’ Desk Reference, (Medical Economics Company, New Jersey, 1998), pp. 2822-2823; David L. Richman, M.D., Leonard

Roy Frank, and Art Mandler, Dr. Caligari’s Psychiatric Drugs (Alonzo Printing Co., Inc., California, 1984), p. 39.

138 Op. cit., David L. Richman, M.D., et al., pp. 38-39.

139 Ibid.

Source: http://www.cchrint.org/pdfs/The_Side_Effects_of_Common_Psychiatric_Drugs.pdf

Related posts

• The Side Effects Of Common Psychiatric Drugs: Newer Antidepressants (0)
• The Side Effects Of Common Psychiatric Drugs: Older Antidepressants (0)
• The Side Effects Of Common Psychiatric Drugs: Anti-Anxiety Drugs (0)
• The Side Effects Of Common Psychiatric Drugs: Lithium (0)
• The Side Effects Of Common Psychiatric Drugs: Psychostimulants (0)
• Valium (diazepam) (0)
• Sertraline (0)
• Zoloft – sertraline HCl (0)
• Tegretol (0)
• XEPLION® (paliperidone palmitate) (0)

FDA ALERT [6/16/2008]: FDA is notifying healthcare professionals that both conventional and atypical antipsychotics are associated with an increased risk of mortality in elderly patients treated for dementia-related psychosis.

In April 2005, FDA notified healthcare professionals that patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death. Since issuing that notification, FDA has reviewed additional information that indicates the risk is also associated with conventional antipsychotics.

Antipsychotics are not indicated for the treatment of dementia-related psychosis.

This information reflects FDA’s current analysis of data available to FDA concerning these drugs. FDA intends to update this sheet when additional information or analyses become available.

To report any serious adverse events associated with the use of this drug, please contact the FDA MedWatch program using the contact information at the bottom of this sheet.

FDA is requiring the manufacturers of conventional antipsychotic drugs to add a Boxed Warning and Warning to the drugs’ prescribing information about the risk of mortality in elderly patients treated for dementia-related psychosis similar to the Boxed Warning and Warning added to the prescribing information of the atypical antipsychotic drugs in 2005.* See the last page of this document for a list of conventional and atypical antipsychotic drugs.

Considerations for Healthcare Professionals

Elderly patients with dementia-related psychosis treated with conventional or atypical antipsychotic drugs are at an increased risk of death.

Antipsychotic drugs are not approved for the treatment of dementia-related psychosis. Furthermore, there is no approved drug for the treatment of dementia-related psychosis. Healthcare professionals should consider other management options.

Physicians who prescribe antipsychotics to elderly patients with dementia-related psychosis should discuss this risk of increased mortality with their patients, patients’ families, and caregivers.

Background Information and Data

Previously, in April 2005, FDA informed healthcare professionals and the public about the increased risk of mortality in elderly patients receiving atypical antipsychotic drugs to treat dementia-related psychosis (April 2005 Public Health Advisory and Information for Healthcare Professionals). At that time, the analyses of 17 placebo-controlled trials that enrolled 5377 elderly patients with dementia-related behavioral disorders revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times that seen in placebo-treated patients. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g. pneumonia) in nature. Based on this analysis, FDA requested that the manufacturers of atypical antipsychotic drugs include information about this risk in a Boxed Warning and the Warnings section of the drugs’ prescribing information.

Recently, two observational epidemiological studies1,2 were published that examined the risk of death in patients who were treated with conventional antipsychotic drugs.

Gill et al.1 performed a retrospective cohort study in Ontario, Canada of 27,259 adults, 66 years of age or older, with a diagnosis of dementia between April 1997 and March 2002. The investigators compared the risk for death with use of an atypical antipsychotic versus no antipsychotic and the risk for death with use of a conventional antipsychotic versus an atypical antipsychotic. They found that atypical antipsychotics were associated with increased mortality as compared to no antipsychotic use as early as 30 days and persisting until study end at 180 days. The investigators found that conventional antipsychotic use showed a marginally higher risk of death compared with atypical antipsychotic use. The causes of death were not reported in this study.

Schneeweiss et al.2 performed a retrospective cohort study in British Columbia, Canada of 37,241 adults, 65 years of age or older, who were prescribed conventional (12,882) or atypical (24,359) antipsychotic medications for any reason between January 1996 and December 2004. The investigators compared the 180-day all cause mortality with use of a conventional antipsychotic versus an atypical antipsychotic. They found that the risk of death in the group of patients treated with conventional antipsychotic medications was comparable to, or possibly greater than, the risk of death in the group of patients treated with atypical antipsychotic medications. The causes of death with the highest relative risk were cancer and cardiac disease.

FDA considers that the methodological limitations in these two studies preclude any conclusion that conventional antipsychotics have a greater risk of death with use than atypical antipsychotics. FDA has determined, however, that the overall weight of evidence, including these studies, indicates that the conventional antipsychotics share the increased risk of death in elderly patients with dementia-related psychosis that has been observed for the atypical antipsychotics. The prescribing information for all antipsychotic drugs will now include the same information about this risk in a Boxed Warning and the Warnings section.

*FDA is requiring the manufacturers to make these changes to the prescribing information for these drugs under its new authority to require safety label changes provided in Title IX of the FDA Amendments Act of 2007 (creating new section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act).

References

1. Gill SS et al. Antipsychotic drug use and mortality in older adults with dementia. Ann Intern Med. 2007;146:775-786

2. Schneeweiss S et al. Risk of death associated with the use of conventional versus atypical antipsychotic drugs among elderly patients. CMAJ. 2007;176:627-632.

Conventional Antipsychotic Drugs Atypical Antipsychotic Drugs

Compazine (prochlorperazine) Abilify (aripiprazole)

Haldol (haloperidol) Clozaril (clozapine)

Loxitane (loxapine) FazaClo (clozapine)

Mellaril (thioridazine) Geodon (ziprasidone)

Moban (molindone) Invega (paliperidone)

Navane (thiothixene) Risperdal (risperidone)

Orap (pimozide) Seroquel (quetiapine)

Prolixin (fluphenazine) Zyprexa (olanzapine)

Stelazine (trifluoperazine) Symbyax (olanzapine and fluoxetine)

Thorazine (chlorpromazine)

Trilafon (perphenazine)

Source: http://www.fda.gov

Related posts

• US Kids Represent Psychiatric Drug Goldmine (1)
• The Side Effects Of Common Psychiatric Drugs: Antipsychotics (0)
• Schizophrenia (0)

Below are some common drug slang terms or drug street names:

STREET NAMES AND SLANG FOR HALLUCINOGENS
Marijuana
Pot, Reefer, Grass, Weed, Dope, Ganja, Mary Jane, or Sinsemilla, Urb,
Hashish
Hash
Mescaline and Peyote
Mesc, Buttons, and Cactus
Psilocybin (Shrooms)
Magic Mushrooms, ‘shrooms
Lysergic acid diethylamide
Acid, Microdot, White lightning, Blue heaven, and Sugar Cubes
Analog of Amphetamines or Methamphetamines
MDMA (Ecstasy, XTC, Adam, Essence), MDM, STP, PMA, 2, 5-DMA, TMA, DOM, DOB, EVE
Phencyclidine
PCP, Hog, Angel Dust, Loveboat, Lovely
Analog of Phencyclidine (PCP)
PCPy, PCE

STREET NAMES AND SLANG FOR DEPRESSANTS
Nitrous Oxide
Laughing gas or Whippets
Amyl Nitrite
Poppers or Snappers
Butyl Nitrite
Rush, Bolt, Bullet, Locker Room, and Climax
Chloro-hydrocarbons
Aerosol sprays or cleaning fluids
Hydrocarbons
Solvents
Barbiturates
Downers, Barbs, Blue Devils, Red Devils, Yellow Jackets,
Yellows, Nembutal, Tuinals, Seconal, and Amytal
Methaqualone
Quaaludes, Ludes, Sopors
Tranquilizers
Valium, Librium, Serax, Equanil, Miltown, and Tranxene

STREET NAMES AND SLANG FOR STIMULANTS
Cocaine
Coke, Snow, Nose Candy, Flake, Blow, Big C, Lady, White, and Snowbirds, Powder,
Crack Cocaine
Crack, rock, freebase, Cookie,
Amphetamines
Speed, Uppers, Ups, Black beauties, Pep pills, Co-pilots, Bumblebees, Hearts, Benzedrine, Dexedrine, Footballs, and Biphetamine
Methamphetamines
Crank, Crystal meth, Crystal methadrine, and Speed
Additional Stimulants
Ritalin, Cylert, Preludin, Didrex, Pre-State, Voranil, Sandrex, and Plegine

STREET NAMES AND SLANG FOR NARCOTICS
Heroin
Smack, Horse, Mud, Brown sugar, Junk, Black tar, and Big H
Morphine
Pectoral syrup
Opium
Paregoric, Dover’s Powder, Parepectolin
Codeine
Empirin compound with codeine, Tylenol with codeine,
Codeine in cough medicine
Meperidine
Pethidine, Demerol, Mepergan
Analog of Fentanyl (Narcotic)
Synthetic heroin, China white
Analog of Meperidine (Narcotic)
MPTP (New heroin), MPPP, synthetic heroin

Source: http://www.njlawman.com/Feature%20Pieces/Drug%20Slang.htm

Related posts

• No related posts.

Two psychiatric medications made the list — Duloxetine (Cymbalta) for a serious risk of urinary retention, and Quetiapine (Seroquel) for overdose due to sample pack labeling confusion.

This is the FDA’s first new public information alert system in years, identifying potential safety issues in drugs and making that information available to the public. The list does not mean that FDA has identified a causal relationship between the drug and the listed risk, but that it’s investigating further to determine if such a relationship exists.

If you’re taking either of the two psychiatric drugs listed, or any of the other listed 18, you should talk to your doctor about the concern the FDA has identified. In terms of Cymbalta, you should talk to your doctor about any problems with retaining urine and in terms of Seroquel, you should double-check with your psychiatrist or doctor to ensure you’ve been prescribed the proper dose.

by John M. Grohol, Psy.D. September 5, 2008
Source: http://psychcentral.com/blog/archives/2008/09/05/two-psychiatric-drugs-on-fda-watch-list/

Related posts

• Your Drug May Be Your Problem (0)
• What medications are used to treat schizophrenia? (0)
• Videos (0)
• Suicide Rates (0)
• Side Effects (0)
• Psychiatry (0)
• PSYCHIATRIC DRUGS: Cure or Quackery? (0)
• How is schizophrenia treated? (0)
• How Do Psychiatric Drugs Work? (0)
• Facts You May Not Know About Psychiatric Drugs (0)

ZYPREXA is a brand name for a prescription medicine that is approved by the FDA for treating the symptoms of schizophrenia, acute mixed or manic episodes of bipolar I disorder and for maintenance treatment in bipolar disorder.

Important Safety Information

Facts About ZYPREXA
ZYPREXA has been prescribed to nearly 24 million people in 84 countries since its approval in 1996

ZYPREXA was the first of a newer generation of antipsychotic medications (called atypical antipsychotics) approved for the long-term treatment of schizophrenia

ZYPREXA was the first atypical antipsychotic approved for the treatment of acute bipolar mania

ZYPREXA has benefits in controlling positive symptoms (hallucinations, delusions) and negative symptoms (apathy, social withdrawal) of schizophrenia

ZYPREXA is easy to use — it can be taken once a day, with or without food

How ZYPREXA® (olanzapine) Works

ZYPREXA is a kind of medication known as an atypical antipsychotic. It belongs to a larger category of medications that affect the mind, called psychotropics. Antipsychotic medicines are psychotropic medications that treat the symptoms of psychotic disorders, such as schizophrenia. They may also be prescribed to treat acute mixed or manic episodes of bipolar disorder.
Antipsychotic Medicines

Antipsychotic medicines are believed to work by balancing the chemicals naturally found in the brain.

Antipsychotic medicines can be used to treat the symptoms of psychosis in schizophrenia, such as hallucinations and delusions, and may improve symptoms, such as fears and voices.

Antipsychotic medicines are also prescribed to treat acute mixed or manic episodes of bipolar disorder. They may improve such symptoms as sleep disturbances, irritability, racing thoughts, and anxiety. Some antipsychotic medications are also prescribed to help control ongoing symptoms.

When you start taking ZYPREXA, keep in mind that it can take several weeks before you notice a difference in the way you feel. The time it takes to experience the full effects of ZYPREXA may vary from person to person, depending on individual symptoms and the dosage prescribed.

It is important to take ZYPREXA the way your doctor has recommended — the right dose, at the same time, every day.

Managing Side Effects

Like any medicine, ZYPREXA may have some side effects. Medicines affect people in different ways. You may experience some of the side effects listed here.
The most common side effects of ZYPREXA are:
Drowsiness
Feeling more hungry than usual
Gaining weight
Dizziness
Dry mouth
Constipation
Upset stomach
Feeling weak
Restlessness
Tremors (shakes)

These side effects generally do not bother people enough to cause them to stop taking ZYPREXA. This is not a complete list of possible side effects. For a more complete list, read the important safety information. If you have questions, be sure to ask your doctor for more information. If you think you may be experiencing side effects, talk with your healthcare provider.

Dosing

Schizophrenia
Usual Dose — Oral olanzapine should be administered on a once-a-day schedule without regard to meals, generally beginning with 5 to 10 mg initially, with a target dose of 10 mg/day within several days. Further dosage adjustments, if indicated, should generally occur at intervals of not less than 1 week, since steady state for olanzapine would not be achieved for approximately 1 week in the typical patient. When dosage adjustments are necessary, dose increments/decrements of 5 mg QD are recommended.

Bipolar Disorder
Usual Monotherapy Dose — Oral olanzapine should be administered on a once-a-day schedule without regard to meals, generally beginning with 10 or 15 mg. Dosage adjustments, if indicated, should generally occur at intervals of not less than 24 hours, reflecting the procedures in the placebo-controlled trials. When dosage adjustments are necessary, dose increments/decrements of 5 mg QD are recommended.

Special Populations — The recommended starting dose is 5 mg in patients who are debilitated, who have a predisposition to hypotensive reactions, who otherwise exhibit a combination of factors that may result in slower metabolism of olanzapine (eg, nonsmoking female patients ≥65 years of age), or who may be more pharmacodynamically sensitive to olanzapine. When indicated, dose escalation should be performed with caution in these patients.

Getting the Most From ZYPREXA® (olanzapine)

Unlike aspirin for a headache or medicine to relieve a cough, you probably can’t feel how ZYPREXA is helping relieve your symptoms. Keep in mind that it can take several weeks before you notice a difference in the way you feel. The time it takes to experience the full effects of ZYPREXA may vary from person to person, depending on individual symptoms and the dosage prescribed.
Create a Routine

It is important to take ZYPREXA the way your doctor has recommended — the right dose, at the same time, every day. Here are a few ways you can help yourself take ZYPREXA properly every day:
Take your medicine on a schedule that’s linked with certain activities you do every day (such as brushing your teeth, taking your vitamins, or eating breakfast or dinner. Or, set your medicine on the nightstand next to your bed or next to your favorite mug on the kitchen counter)

Organize your pills in a pill counter to keep track of the doses you’ve taken

Use a calendar to keep track of the doses you’ve taken

Ask your doctor if your medicine schedule can be changed so that you take fewer doses each day

Source: http://www.zyprexa.com/about_zyprexa.jsp

Related posts

• Latuda (0)
• DSM-IV for Schizophrenia (0)
• The Side Effects Of Common Psychiatric Drugs: Older Antidepressants (0)
• The Side Effects Of Common Psychiatric Drugs: Newer Antidepressants (0)
• Schizophrenia (0)
• Mental Health Medications (0)
• Cognitive Behavioral Therapy (0)
• Child and Adolescent Mental Illness Statistics (0)
• Zeldox (ziprasidone) (0)
• Your Drug May Be Your Problem (0)

Antipsychotics can be classified by their structure but can also be distinguished by their pharmacology, their action at receptors, and by their clinical properties. Typical (also called conventional) antipsychotics act primarily at dopamine receptors. Atypical antipsychotics act on other receptors as well as dopamine, and are less likely than typical antipsychotics to cause movement disorders as a side effect. The following are atypical antipsychotics are licensed in the UK: amisulpiride (brand name Solian), aripiprazole (Abilify), clozapine (Clozaril), olanzapine (Zyprexa), quetiapine (Seroquel), risperidone (Risperdal) and zotepine (Zoleptil).

As with all effective medicines antipsychotics can produce side effect in some individuals. The most common side effects include movement disorders that may resemble Parkinson’s disease (referred to as extrapyramidal effects, anticholinergic effects such as dry mouth, feelings of dizziness or light headedness, constipation and blurred vision (so called as they are due to the action of these drugs on cholinergic receptors in the brain and body) and weight gain.

It is important to appreciate that this is not a comprehensive list of the possible side effects of antipsychotics. Full guidance on prescribing and use, including possible side effects, of antipsychotics is provided in the Summary of Product Characteristics (SPC) for health professionals and the patient information leaflet (PIL) that should accompany the medicine.

More recently concerns have arisen that patients receiving risperidone and olanzapine in dementia were at an increased risk of stroke compared with patients receiving placebo (dummy pill) and that the balance of risks and benefits was considered to be unfavourable in the dementia population. Atypical antipsychotics are not authorised for the treatment of dementia related psychosis and/or behaviour disturbances. Prescribers were informed of this risk and advised to review the treatment of all patients receiving atypical antipsychotics in dementia as the risk of stroke for other atypical antipsychotics could not be excluded:
Source: http://www.mhra.gov.uk/Safetyinformation/Generalsafetyinformationandadvice/Product-specificinformationandadvice/Antipsychoticdrugs/index.htm

Related posts

• The Side Effects Of Common Psychiatric Drugs: Newer Antidepressants (0)
• XEPLION® (paliperidone palmitate) (0)
• Valium (diazepam) (0)
• The Side Effects Of Common Psychiatric Drugs: Psychostimulants (0)
• The Side Effects Of Common Psychiatric Drugs: Antipsychotics (0)
• The Side Effects Of Common Psychiatric Drugs: Anti-Anxiety Drugs (0)
• Sertraline (0)
• Methylene Blue and Psychiatric Medications (0)
• Latuda (0)
• Cymbalta – duloxetine HCl (0)